System, an apparatus, and a method for treating a sexual dysfunctional female patient

ABSTRACT

There is disclosed an apparatus for treating a sexual dysfunctional female patient, comprising a stimulation device adapted to stimulate an erectile blood flow passageway to increase the amount of blood in the female erectile tissue and thereby obtaining engorgement with blood of the female erectile tissue by affecting said erectile blood flow passageway. Moreover there is disclosed a system and an operation method for treating a sexual dysfunctional female patient.

TECHNICAL FIELD

The present invention relates to the treatment of sexual dysfunction ina female patient, as well as a system and an apparatus for the purpose.

BACKGROUND

A lot of attention has been given to male sexual disorders includingimpotency. This has lead to the availability of a number of treatmentoptions for males, including pharmaceuticals such as Viagra.

In contrast, there is a lack of therapies for treating Female sexualdysfunction. Female sexual dysfunction such as disorders of sexualdesire, arousal or orgasm is a common problem, affecting up to 43% ofall women (Pauls et al, Obstret Gynecol Surv, 2005 60(3):3196-205). Bothbiological and psychological factors contribute to FSD.

Available treatments include psychological counselling to pairs orindividuals. Where side effects of medication contribute to FSD,altering medication or dosage may help.

During sexual arousal of the female, vasocongestion of the pelvic regionleads to engorgement of the genitalia with blood leading to swelling ofthe external genitalia and erection of the clitoris. This is accompaniedby lubrication of the vagina. In the female, the corpus cavernosa aretwo paired symmetrical extensions of the clitoris and engorgement ofthese is an important step during sexual arousal of the female.

Female sexual arousal is enhanced by stimulation of the vulva, bytouching or caressing the clitoris, which contributes to arousal.

Hand held or other external devices that stimulate the clitoris arewell-known. For example U.S. Pat. No. 7,081,087 discloses a sexual aidthat vibrates. There has been proposed a device for treating FSD thatapplies a vacuum or suction to the clitoris. This will create a negativepressure that promotes the engorgement of the clitoris with blood(Hovland Claire, U.S. Pat. No. 6,464,653).

The proposed device is implanted. An advantage with the implantation ofa stimulating device is that it is always at hand and can convenientlybe switched on before sexual intercourse. Hand held devices are morelikely to cause embarrassment.

The local administration of prostaglandins to the female genetalia inorder to treat FSD has been described in U.S. Pat. No. 6,486,207).

The implantation of an electrode that stimulates the peripheral nervesof the vulva has been described (US 2008/0103544).

In spite of the available treatments there is still a need for improvedtreatment of female sexual dysfunction.

SUMMARY OF THE INVENTION

It is an object of the present invention to obviate at least some of thedisadvantages in the prior art.

One advantage of the present invention is that the likelihood to getorgasm will increase by the stimulation device.

Another advantage of the present invention is that the sexual responseto sexual stimuli will increase.

In a first aspect there is provided an apparatus for treating a sexualdysfunctional female patient, comprising a stimulation device adapted tostimulate an erectile blood flow passageway to increase the amount ofblood in the female erectile tissue and thereby obtaining engorgementwith blood of the female erectile tissue by affecting said erectileblood flow passageway.

In a second aspect there is provided a system comprising an apparatusaccording to the invention.

In a third aspect there is provided an operation method using anapparatus according to the invention, comprising the steps of: a)creating an opening in the skin or vaginal wall of the female patient b)dissecting at least one area of the female erectile tissue, and c)placing the stimulation device within said area, adapted topostoperatively stimulate said female erectile tissue on patientcommand.

Further aspects and embodiments are defined in the appended claims,which are specifically incorporated herein by reference.

DEFINITIONS

The term “female erectile tissue” refers to tissue of the female sexualorgans that before or during sexual intercourse are filled with bloodincluding the corpora cavernosa, the vestibular bulbs and the clitoris

The term “free flow” as used throughout the description and the termsdenotes a fluid passageway unaffected by any artificial stimulation inany direction, such as valves or return valves.

The term “tissue” as used throughout the description and the claimsdenotes a cellular organizational level intermediate between cells and acomplete organism. Hence, a tissue is an ensemble of cells, notnecessarily identical, but from the same origin, that together carry outa specific function. For example tissue includes bone.

In general terms the present invention relates an apparatus and methodsof treating a sexual dysfunctional female patient which comprises astimulation device for stimulating the erectile tissues of a femalepatient. In accordance with the invention stimulation can be performedby stimulating so as to affect blood passageways to or from the erectiletissues. The present invention also relates to the accomplishment ofstimulation directly on the corpus cavernosa and thereby affectsstimulation of glands assisting with their secretion of fluidsassociated with natural engorgement. These mentioned routes ofstimulation can either be performed separately or in combination withany apparatus of the invention.

In a first aspect there is provided an apparatus for treating a sexualdysfunctional female patient, comprising a stimulation device adapted tostimulate an erectile blood flow passageway to increase the amount ofblood in the female erectile tissue and thereby obtaining engorgementwith blood of the female erectile tissue by affecting said erectileblood flow passageway.

In one embodiment there is provided an apparatus comprising astimulation device that is able to restrict the blood flow passagewayleaving the female erectile tissue.

In one embodiment there is provided an apparatus, wherein saidstimulation device engages at least one selected from the groupconsisting of: a venous blood vessel leading from said female erectiletissue, a corpus cavernosum, a vestibular bulb and a muscle affectingblood flow that drains the female erectile tissue; said stimulationdevice being adapted to temporarily and at least partially restrict thecross-sectional area of such erectile blood flow passageway that drainsthe female erectile tissue.

In one embodiment there is provided an apparatus, comprising two or morestimulation devices post-operatively and non-invasively adjustable.

In one embodiment there is provided an apparatus, further comprising animplantable control unit for adjusting the stimulation device totemporarily contract the female erectile tissue to restrict the bloodflow leaving the female erectile tissue.

In one embodiment there is provided an apparatus, comprising a controldevice comprising an implanted control unit adapted to control andadjust electrical parameters of said stimulation device, wherein saidcontrol unit is programmable from outside the female patient's body.

In one embodiment there is provided an apparatus, wherein thestimulation device comprises at least one electrical electrode tostimulate the female erectile tissue to achieve engorgement of saidfemale erectile tissue.

In one embodiment there is provided an apparatus, further comprising analarm adapted to generate an alarm signal in response to the lapse of apredetermined time period during which the stimulation device has beenoperating.

In one embodiment there is provided an apparatus, wherein thestimulation device comprises at least one elongated stimulation memberadapted to form the stimulation member into at least a substantiallyclosed loop around a portion of the female erectile tissue, the loopdefining a stimulation opening.

In one embodiment there is provided an apparatus, wherein thestimulation device comprises at least two stimulation device electrodes.

In one embodiment there is provided an apparatus, wherein thestimulation device adapted to increase the arterial blood flow reachingthe female erectile tissue causing engorgement with blood of the femaleerectile tissue.

In one embodiment there is provided an apparatus, wherein the flow ofblood is increased by enlarging the cross-sectional area of the bloodflow passageway, comprising said at least one artery.

In one embodiment there is provided an apparatus, wherein saidstimulation device, comprising a heating member causing engorgement withblood of the female erectile tissue.

In one embodiment there is provided an apparatus, wherein saidstimulation device stimulates a muscle related to said blood flowreaching the female erectile tissue.

In one embodiment there is provided an apparatus, wherein saidstimulation device is adapted to stimulate said muscle, to causerelaxation of said muscle to increase said arterial blood flow.

In one embodiment there is provided an apparatus, wherein saidstimulation device is adapted to stimulate said muscle excessively torelax said muscle.

In one embodiment there is provided an apparatus, wherein saidstimulation device stimulates a muscle related to said blood flowleaving the female erectile tissue.

In one embodiment there is provided an apparatus, wherein saidstimulation device is adapted to stimulate said muscle in order toinduce contraction of said muscle to restrict said erectile blood flowpassageway.

In one embodiment there is provided an apparatus, wherein saidstimulation device is powered.

In one embodiment there is provided an apparatus, comprising a controldevice, wherein the control device controls the stimulation device toshift over time the stimulation from one area of one wall portion of theerectile blood flow passageway to another.

In one embodiment there is provided an apparatus, wherein said controldevice controls the stimulation device to cyclically propagate thestimulation to areas along the wall in the same or opposite direction ofthe flow in the patient's erectile blood flow passageway.

In one embodiment there is provided an apparatus, wherein the controldevice controls the stimulation device to propagate the stimulation ofthe areas in accordance with a determined stimulation pattern.

In one embodiment there is provided an apparatus, comprising a controldevice, wherein the control device controls the stimulation device tovary the intensity of the stimulation of the erectile blood flowpassageway.

In one embodiment there is provided an apparatus, wherein the controldevice controls the stimulation device to cyclically vary the intensityof the stimulation of said erectile blood flow passageway.

In one embodiment there is provided an apparatus, wherein the controldevice controls the stimulation device to intermittently andindividually stimulate different areas of the erectile blood flowpassageway with pulses.

In one embodiment there is provided an apparatus, wherein the controldevice controls the stimulation device to intermittently stimulate theareas with the pulses.

In one embodiment there is provided an apparatus, wherein said pulsesform pulse trains.

In one embodiment there is provided an apparatus, wherein the controldevice controls the stimulation device to vary the amplitudes of thepulses of the pulse trains.

In one embodiment there is provided an apparatus, wherein the controldevice controls the stimulation device to vary the off time periodsbetween the individual pulses of each pulse train.

In one embodiment there is provided an apparatus, wherein the controldevice controls the stimulation device to vary the width of each pulseof the pulse trains.

In one embodiment there is provided an apparatus, wherein the controldevice controls the stimulation device to vary the frequency of thepulses of the pulse trains.

In one embodiment there is provided an apparatus, wherein the controldevice controls the stimulation device to vary the off time periodsbetween the pulse trains.

In one embodiment there is provided an apparatus, wherein the controldevice controls the stimulation device to vary the length of each pulsetrain.

In one embodiment there is provided an apparatus, wherein the controldevice controls the stimulation device to vary the frequency of thepulse trains.

In one embodiment there is provided an apparatus, wherein the controldevice controls the stimulation device to vary the number of pulses ofeach pulse train.

In one embodiment there is provided an apparatus, wherein thestimulation device intermittently and individually electricallystimulates different areas of said erectile blood flow passageway.

In one embodiment there is provided an apparatus, wherein saidstimulation device comprises at least one electrical electrode forengaging at least one portion of the wall of the erectile blood flowpassageway and stimulating at least one portion of the wall thereof withelectric pulses.

In one embodiment there is provided an apparatus, wherein thestimulation device comprises a plurality of electrical elements.

In one embodiment there is provided an apparatus, wherein the electricalelements are placed in a fixed orientation relative to one another.

In one embodiment there is provided an apparatus, wherein thestimulation device comprises a structure holding the electrical elementsin the fixed orientation.

In one embodiment there is provided an apparatus, wherein the electricalelements form an elongate pattern of electrical elements, and thestructure is applicable on the patient's erectile blood flow passagewaysuch that the elongate pattern of electrical elements extends along atleast one portion of the wall of the erectile blood flow passageway inthe direction of the flow in the patient's erectile blood flowpassageway and the elements abut the respective areas of the wallportion.

In one embodiment there is provided an apparatus, wherein said structureis integrated in said stimulation.

In one embodiment there is provided an apparatus, wherein said structureis separate from said stimulation device.

In one embodiment there is provided an apparatus, wherein said controldevice controls said stimulation device to electrically energize saidelectrical elements.

In one embodiment there is provided an apparatus, wherein said controldevice controls said stimulation device to cyclically energize eachelement with electric pulses.

In one embodiment there is provided an apparatus, wherein said controldevice controls said stimulation device to energize said electricalelements, such that a number or groups of said electrical elements areenergized at the same time.

In one embodiment there is provided an apparatus, wherein said controldevice controls said stimulation device to energize said electricalelements, such that said electrical elements are energized one at a timein sequence or groups of said electrical elements are sequentiallyenergized, either randomly or in accordance with a predeterminedpattern.

In one embodiment there is provided an apparatus, wherein saidelectrical elements form an elongate pattern of electrical elements, andsaid elements are applicable on the patient's wall such that saidelongate pattern of electrical elements extends along the wall at leastone portion of the wall of the erectile blood flow passageway in thedirection of the flow in the patient's erectile blood flow passagewayand the elements abut the respective areas of the wall portion.

In one embodiment there is provided an apparatus, wherein said controldevice controls said stimulation device to successively energize saidelectrical elements longitudinally along said elongate pattern ofelectrical elements.

In one embodiment there is provided an apparatus, wherein said controldevice controls said stimulation device to successively energize saidelectrical elements along said elongate pattern of electrical elementsin a direction opposite to, or in the same direction as, that of theflow in the patient's erectile blood flow passageway, when saidstimulation device is applied on the patient's erectile blood flowpassageway.

In one embodiment there is provided an apparatus, wherein said controldevice controls said stimulation device to successively energize saidelectrical elements from a position substantially at the center of theconstricted wall portion towards both ends of the elongate pattern ofelectrical elements, when said stimulation device is applied on theerectile blood flow passageway.

In one embodiment there is provided an apparatus, wherein said controldevice controls said stimulation device to energize said electricalelements, such that electrical elements currently energized form atleast one group of adjacent energized electrical elements.

In one embodiment there is provided an apparatus, wherein said elementsin said group of energized electrical elements form a path of energizedelectrical elements.

In one embodiment there is provided an apparatus, wherein said path ofenergized electrical elements extends at least in part around thepatient's erectile blood flow passageway, when said stimulation deviceis applied on the erectile blood flow passageway.

In one embodiment there is provided an apparatus, wherein said path ofenergized electrical elements extends completely around the patient'serectile blood flow passageway, when said stimulation device is appliedon the erectile blood flow passageway.

In one embodiment there is provided an apparatus, wherein said elementsin said group of energized electrical elements form two paths ofenergized electrical elements extending opposite to each other, whensaid stimulation device is applied on the patient's erectile blood flowpassageway.

In one embodiment there is provided an apparatus, wherein said two pathsof energized electrical elements extend on mutual sides of the patient'serectile blood flow passageway and at least substantially transverse tothe direction of flow in the erectile blood flow passageway, when saidstimulation device is applied on the erectile blood flow passageway.

In one embodiment there is provided an apparatus, wherein saidelectrical elements form a plurality of groups of elements, the groupsforming a series of groups extending along the patient's erectile bloodflow passageway in the direction of flow in the erectile blood flowpassageway, when said stimulation device is applied on the erectileblood flow passageway.

In one embodiment the apparatus, comprises, in addition to a stimulationdevice, an implantable restriction device that engages the femaleerectile tissue or at least one venous blood vessel that drains thefemale erectile tissue and that is able to restrict the venous bloodflow leaving the female erectile tissue. The restriction device maycomprise a clamp or a loop and may be adjustable. The adjustment may beachieved with a hydraulic, mechanical, electrical or magnetic mean; orcombinations thereof. The restriction device may be controlled, poweredand energized in the same manner as the stimulation device and may be anintegrated part of the system (se below).

In a second aspect there is provided a system comprising an apparatus asdescribed above.

In one embodiment there is provided a system, further comprising atleast one switch implantable in the patient for manually andnon-invasively controlling the apparatus.

In one embodiment there is provided a system, further comprising ahydraulic device having an implantable hydraulic reservoir, which ishydraulically connected to the apparatus, wherein the apparatus isadapted to be non-invasively regulated by manually pressing thehydraulic reservoir.

In one embodiment there is provided a system, further comprising awireless remote control for non-invasively controlling the apparatus.

In one embodiment there is provided a system, wherein the wirelessremote control comprises at least one external signal transmitter and/orreceiver, further comprising an internal signal receiver and/ortransmitter implantable in the patient for receiving signals transmittedby the external signal transmitter or transmitting signals to theexternal signal receiver.

In one embodiment there is provided a system, wherein the wirelessremote control transmits at least one wireless control signal forcontrolling the apparatus.

In one embodiment there is provided a system, wherein the wirelesscontrol signal comprises a frequency, amplitude, or phase modulatedsignal or a combination thereof.

In one embodiment there is provided a system, wherein the wirelessremote control transmits an electromagnetic carrier wave signal forcarrying the control signal.

In one embodiment there is provided a system, further comprising awireless energy-transmission device for non-invasively energizingimplantable energy consuming components of the apparatus or the systemwith wireless energy.

In one embodiment there is provided a system, wherein the wirelessenergy comprises a wave signal selected from the following: a sound wavesignal, an ultrasound wave signal, an electromagnetic wave signal, aninfrared light signal, a visible light signal, an ultra violet lightsignal, a laser light signal, a micro wave signal, a radio wave signal,an x-ray radiation signal and a gamma radiation signal.

In one embodiment there is provided a system, wherein the wirelessenergy comprises one of the following: an electric field, a magneticfield, a combined electric and magnetic field.

In one embodiment there is provided a system, wherein the control signalcomprises one of the following: an electric field, a magnetic field, acombined electric and magnetic field.

In one embodiment there is provided a system, wherein the signalcomprises an analogue signal, a digital signal, or a combination of ananalogue and digital signal

In one embodiment there is provided a system, further comprising animplantable internal energy source for powering implantable energyconsuming components of the apparatus.

In one embodiment there is provided a system, further comprising anexternal energy source for transferring energy in a wireless mode,wherein the internal energy source is chargeable by the energytransferred in the wireless mode.

In one embodiment there is provided a system, further comprising asensor or measuring device sensing or measuring a functional parametercorrelated to the transfer of energy for charging the internal energysource, and a feedback device for sending feedback information frominside the patient's body to the outside thereof, the feedbackinformation being related to the functional parameter sensed by thesensor or measured by the measuring device.

In one embodiment there is provided a system, further comprising afeedback device for sending feedback information from inside thepatient's body to the outside thereof, the feedback information beingrelated to at least one of a physiological parameter of the patient anda functional parameter related to the apparatus.

In one embodiment there is provided a system, further comprising asensor and/or a measuring device and an implantable internal controlunit for controlling the apparatus in response to information beingrelated to at least one of a physiological parameter of the patientsensed by the sensor or measured by the measuring device and afunctional parameter related to the apparatus sensed by the sensor ormeasured by the measuring device.

In one embodiment there is provided a system, wherein the physiologicalparameter is a pressure or motility.

In one embodiment there is provided a system, further comprising anexternal data communicator and an implantable internal data communicatorcommunicating with the external data communicator, wherein the internalcommunicator feeds data related to the apparatus or the patient to theexternal data communicator and/or the external data communicator feedsdata to the internal data communicator.

In one embodiment there is provided a system, further comprising anenergy-transforming device for transforming the wireless energytransmitted by the energy-transmission device from a first form into asecond form energy.

In one embodiment there is provided a system, wherein theenergy-transforming device directly powers implantable energy consumingcomponents of the apparatus with the second form energy, as theenergy-transforming device transforms the first form energy transmittedby the energy-transmission device into the second form energy.

In one embodiment there is provided a system, wherein the second formenergy comprises at least one of a direct current, pulsating directcurrent and an alternating current.

In one embodiment there is provided a system, further comprising animplantable accumulator, wherein the second form energy is used at leastpartly to charge the accumulator.

In one embodiment there is provided a system, wherein the energy of thefirst or second form comprises at least one of magnetic energy, kineticenergy, sound energy, chemical energy, radiant energy, electromagneticenergy, photo energy, nuclear energy thermal energy, non-magneticenergy, non-kinetic energy, non-chemical energy, non-sonic energy,non-nuclear energy and non-thermal energy.

In one embodiment there is provided a system, further comprisingimplantable electrical components including at least one voltage levelguard and/or at least one constant current guard.

In one embodiment there is provided a system, further comprising acontrol device for controlling the transmission of wireless energy fromthe energy-transmission device, and an implantable internal energyreceiver for receiving the transmitted wireless energy, the internalenergy receiver being connected to implantable energy consumingcomponents of the apparatus for directly or indirectly supplyingreceived energy thereto, the system further comprising a determinationdevice adapted to determine an energy balance between the energyreceived by the internal energy receiver and the energy used for theimplantable energy consuming components of the apparatus, wherein thecontrol device controls the transmission of wireless energy from theexternal energy-transmission device, based on the energy balancedetermined by the determination device.

In one embodiment there is provided a system, wherein the determinationdevice is adapted to detect a change in the energy balance, and thecontrol device controls the transmission of wireless energy based on thedetected energy balance change.

In one embodiment there is provided a system, wherein the determinationdevice is adapted to detect a difference between energy received by theinternal energy receiver and energy used for the implantable energyconsuming components of the apparatus, and the control device controlsthe transmission of wireless energy based on the detected energydifference.

In one embodiment there is provided a system, wherein theenergy-transmission device comprises a coil placed externally to thehuman body, further comprising an implantable energy receiver to beplaced internally in the human body and an electric circuit connected topower the external coil with electrical pulses to transmit the wirelessenergy, the electrical pulses having leading and trailing edges, theelectric circuit adapted to vary first time intervals between successiveleading and trailing edges and/or second time intervals betweensuccessive trailing and leading edges of the electrical pulses to varythe power of the transmitted wireless energy, the energy receiverreceiving the transmitted wireless energy having a varied power.

In one embodiment there is provided a system, wherein the electriccircuit is adapted to deliver the electrical pulses to remain unchangedexcept varying the first and/or second time intervals.

In one embodiment there is provided a system, wherein the electriccircuit has a time constant and is adapted to vary the first and secondtime intervals only in the range of the first time constant, so thatwhen the lengths of the first and/or second time intervals are varied,the transmitted power over the coil is varied.

In one embodiment there is provided a system, further comprising animplantable internal energy receiver for receiving wireless energy, theenergy receiver having an internal first coil and a first electroniccircuit connected to the first coil, and an external energy transmitterfor transmitting wireless energy, the energy transmitter having anexternal second coil and a second electronic circuit connected to thesecond coil, wherein the external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver, the system further comprising a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off.

In one embodiment there is provided a system, further comprising animplantable internal energy receiver for receiving wireless energy, theenergy receiver having an internal first coil and a first electroniccircuit connected to the first coil, and an external energy transmitterfor transmitting wireless energy, the energy transmitter having anexternal second coil and a second electronic circuit connected to thesecond coil, wherein the external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver, the system further comprising a feedback device forcommunicating out the amount of energy received in the first coil as afeedback information, and wherein the second electronic circuit includesa determination device for receiving the feedback information and forcomparing the amount of transferred energy by the second coil with thefeedback information related to the amount of energy received in thefirst coil to obtain the coupling factors between the first and secondcoils.

In one embodiment there is provided a system, wherein the energytransmitter regulates the transmitted energy in response to the obtainedcoupling factor.

In one embodiment there is provided a system, wherein external secondcoil is adapted to be moved in relation to the internal first coil toestablish the optimal placement of the second coil, in which thecoupling factor is maximized.

In one embodiment there is provided a system, wherein the externalsecond coil is adapted to calibrate the amount of transferred energy toachieve the feedback information in the determination device, before thecoupling factor is maximized.

In addition, the stimulation device may comprise at least one elongatedstimulation member adapted to form the stimulation member into at leasta substantially closed loop around a portion of the female erectiletissue, the loop defining a stimulation opening, whereby the stimulationdevice is adapted to adjust the size of the stimulation opening.

In an alternative embodiment the apparatus may comprise a stimulationdevice adapted to increase the arterial blood flow reaching the femaleerectile tissue causing engorgement with blood of the female erectiletissue.

The stimulation device may comprise a heating member causing engorgementwith blood of the female erectile tissue. Alternatively a muscleaffecting the blood flow is stimulated. In one embodiment a relaxationof said muscle may be achieved by excessive stimulation thereof.

Electric Stimulation

When stimulating female erectile tissue such as the corpus cavernosa orvestibular bulbs or venous blood vessels draining the female erectiletissue or muscular tissue affecting the blood flow leaving or arrivingto the female erectile tissue or arterial blood vessels supplying bloodto the female erectile tissue, an engorgement of said female erectiletissue occur. All the above is defined the erectile blood flowpassageway.

In accordance with the present invention, the control device controlsthe stimulation device to intermittently stimulate different areas ofthe wall portion of the erectile blood flow passageway, such that atleast two of the areas are stimulated at different points of time thatis, the stimulation is shifted from one area to another area over time.Furthermore, the control device controls the stimulation device tostimulate each area during successive time periods, wherein each timeperiod is short enough to maintain satisfactory blood circulation in thearea until the lapse of the time period. This gives the advantage thatthe apparatus of the present invention enables continuous stimulation ofthe wall portion of the erectile blood flow passageway to achieve thedesired flow control, while essentially maintaining over time thenatural physiological properties of the erectile blood flow passagewaywithout risking injuring the erectile blood flow passageway.

Also, by physiologically changing the places of stimulation on theerectile blood flow passageway over time as described above it ispossible to create an advantageous changing stimulation pattern on theerectile blood flow passageway, in order to achieve a desired flowcontrol.

The control device may control the stimulation device to stimulate oneor more of the areas of the wall portion at a time, for example bysequentially stimulating the different areas. Furthermore, the controldevice may control the stimulation device to cyclically propagate thestimulation of the areas along the wall portion, preferably inaccordance with a determined stimulation pattern. To achieve the desiredreaction of the tissue wall of the erectile blood flow passageway duringthe stimulation thereof, the control device may control the stimulationdevice to, preferably cyclically, vary the intensity of the stimulationof the wall portion.

In a preferred embodiment of the invention, the control device controlsthe stimulation device to intermittently stimulate the areas of the wallportion with pulses that preferably form pulse trains. The pulse trainscan be configured in many different ways. Thus, the control device maycontrol the stimulation device to vary the amplitudes of the pulses ofthe pulse trains, the duty cycle of the individual pulses of each pulsetrain, the width of each pulse of the pulse trains, the length of eachpulse train, the repetition frequency of the pulses of the pulse trains,the repetition frequency of the pulse trains, the number of pulses ofeach pulse train, and/or the off time periods between the pulse trains.Several pulse trains of different configurations may be employed toachieve the desired effect.

In case the control device controls the stimulation device to vary theoff time periods between pulse trains that stimulate the respective areaof the wall portion, it is also possible to control each off time periodbetween pulse trains to last long enough to restore substantially normalblood circulation in the area when the latter is not stimulated duringthe off time periods.

In accordance with a preferred embodiment of the invention, thestimulation device is an electrically powered stimulation device thatelectrically stimulates the tissue wall portion of the erectile bloodflow passageway, preferably with electric pulses.

Alternatively only the muscle tissue related to the blood flow in theerectile blood flow passageway may be stimulated. Over stimulation ofmuscle tissue may cause a relaxation of said tissue thus provokingengorgement of said rectile tissue. When talking about wall portion thisincludes also muscle tissue in any relevant position in thisapplication.

The control device controls the stimulation device to stimulate the wallportion with electric pulses preferably in the form of electric pulsetrains, to cause contraction of the wall portion. Of course, theconfiguration of the electric pulse trains may be similar to the abovedescribed pulse trains and the control device may control thestimulation device to electrically stimulate the different areas of thewall of the erectile blood flow passageway in the same manner asdescribed above.

The electric stimulation device suitably comprises at least one,preferably a plurality of electrical elements, such as electrodes, forengaging and stimulating the wall portion with electric pulses.Optionally, the electrical elements may be are placed in a fixedorientation relative to one another. The control device controls theelectric stimulation device to electrically energize the electricalelements, one at a time, or groups of electrical elements at a time.Preferably, the control device controls the electric stimulation deviceto cyclically energize each element with electric pulses. Optionally,the control device may control the stimulation device to energize theelectrical elements, such that the electrical elements are energized oneat a time in sequence, or such that a number or groups of the electricalelements are energized at the same time. Also, groups of electricalelements may be sequentially energized, either randomly or in accordancewith a predetermined pattern.

The electrical elements may form any pattern of electrical elements.Preferably, the electrical elements form an elongate pattern ofelectrical elements, wherein the electrical elements are applicable onthe patient's wall of the erectile blood flow passageway, such that theelongate pattern of electrical elements extends lengthwise along thewall of the erectile blood flow passageway, and the elements abut therespective areas of the wall portion. The elongate pattern of electricalelements may include one or more rows of electrical elements extendinglengthwise along the wall of the erectile blood flow passageway. Eachrow of electrical elements may form a straight, helical or zig-zag pathof electrical elements, or any form of path. The control device maycontrol the stimulation device to successively energize the electricalelements longitudinally along the elongate pattern of electricalelements in a direction opposite to, or in the same direction as thatof, the flow in the patient's rectile blood flow passageway.

Optionally, the control device may control the stimulation device tosuccessively energize the electrical elements from a positionsubstantially at the center of the constricted wall portion towards bothends of the elongate pattern of electrical elements. Where the lumen ofthe organ erectile blood flow passageway is to be kept closed for arelatively long time, the control device may control the stimulationdevice to energize the electrical elements, such that energizedelectrical elements form two waves of energized electrical elements thatsimultaneously advance from the center of the constricted wall portionin two opposite directions towards both ends of the elongate pattern ofelectrical elements. Such waves of energized electrical elements can berepeated over and over again without harming the erectile blood flowpassageway and without moving blood in any direction in the erectileblood flow passageway.

The control device suitably controls the stimulation device to energizethe electrical elements, such that the electrical elements currentlyenergized form at least one group of adjacent energized electricalelements. In accordance with a first alternative, the elements in thegroup of energized electrical elements form one path of energizedelectrical elements. The path of energized electrical elements mayextend at least in part around the patient's erectile blood flowpassageways. In a second alternative, the elements of the group ofenergized electrical elements may form two paths of energized electricalelements extending on mutual sides of the patient's erectile blood flowpassageway, preferably substantially transverse to the flow direction inthe lumen of the erectile blood flow passageway. In a third alternative,the elements of the group of energized electrical elements may form morethan two paths of energized electrical elements extending on differentsides of the patient's erectile blood flow passageway, preferablysubstantially transverse to the flow direction in the patient'slumenerectile blood flow passageway.

In accordance with a preferred embodiment of the invention, theelectrical elements form a plurality of groups of elements, wherein thegroups form a series of groups extending along the patient's erectileblood flow passageway in the flow direction in the patient'slumenerectile blood flow passageway. The electrical elements of eachgroup of electrical elements may form a path of elements extending atleast in part around the patient's erectile blood flow passageway. In afirst alternative, the electrical elements of each group of electricalelements may form more than two paths of elements extending on differentsides of the patient's erectile blood flow passageway, preferablysubstantially transverse to the flow direction in the patient'slumenerectile blood flow passageway. The control device may control thestimulation device to energize the groups of electrical elements in theseries of groups in random, or in accordance with a predeterminedpattern.

Alternatively, the control device may control the stimulation device tosuccessively energize the groups of electrical elements in the series ofgroups in a direction opposite to the flow in the patient'slumenerectile blood flow passageway, or in both said directions startingfrom a position substantially at the center of the constricted wallportion. For example, groups of energized electrical elements may formadvancing waves of energized electrical elements, as described above;that is, the control device may control the stimulation device toenergize the groups of electrical elements, such that energizedelectrical elements form two waves of energized electrical elements thatsimultaneously advance from the center of the constricted wall portionin two opposite directions towards both ends of the elongate pattern ofelectrical elements.

A structure may be provided for holding the electrical elements in afixed orientation. Although the structure may be separate from thestimulation device, it is preferable that the structure is integrated inthe stimulation device, which is a practical design and facilitatesimplantation of the stimulation devices. Where the electrical elementsform an elongate pattern of electrical elements, the structure may beapplicable on the patient's erectile blood flow passageway such that theelongate pattern of electrical elements extends along the erectile bloodflow passageway in the same direction as that of the flow in thepatient's lumenerectile blood flow passageway and the elements abut therespective areas of the wall portion of the erectile blood flowpassageway.

Thermal Stimulation

In another embodiment of the invention, the stimulation device thermallystimulates the wall portion of the erectile blood flow passageway. Thus,the control device may control the stimulation device to cool the wallportion, when the wall portion is constricted, to cause contraction ofthe wall portion. For example, the control device may control thestimulation device to cool the constricted wall portion to causecontraction thereof, such that the flow in the lumen erectile blood flowpassageway is at least further restricted, or further restricted but notstopped, or stopped. Alternatively, the control device may control thestimulation device to heat the arterial wall portion, when the wallportion is constricted and contracted, to cause expansion of the wallportion. Where the wall portion includes venous erectile blood flowpassageway, the control device may control the stimulation device tocool the erectile blood flow passageway to cause contraction thereof, orheat the artierial erectile blood flow passageway to cause expansionthereof. Where applicable, thermal stimulation may be practised in anyof the embodiments of the present invention, and the thermal stimulationmay be controlled in response to various sensors, for example strain,motion or pressure sensors.

Sensor Controlled Stimulation Device

The apparatus may further comprising a control device for manuallycontrolling the at least one stimulation device from outside thepatients body, and may further comprise a control device for controllingthe level of stimulation.

The apparatus preferable comprising a control device for adjusting thestimulation device to temporarily contract the female erectile tissue torestrict the blood flow leaving the female erectile tissue.

Alternatively the apparatus may comprise a control device and at leastone sensor adapted to detect a physiological parameter of the patientand/or a functional parameter of the apparatus, wherein said controldevice comprises a control unit adapted to automatically control the atleast one stimulation device based on input from said at least onesensor.

As mentioned above, the apparatus may comprise at least one implantablesensor, wherein the control device controls the constriction deviceand/or the stimulation device in response to signals from the sensor.Generally, the sensor directly or indirectly senses at least onephysiological parameter of the patient, or at least one functionalparameter of the apparatus, or at least one functional parameter of amedical implant in the patient.

Many different kinds of sensor for sensing physiological parameters maybe used. For example pressure sensors for sensing pressure in theerectile blood flow passageway, strain sensors for sensing strain of theerectile blood flow passageway, flow sensors for sensing blood flow inthe lumen of the erectile blood flow passageway, spectrophotometricalsensors, or sensors for sensing the distribution of the stimulation onthe stimulated erectile blood flow passageway. Any conceivable sensorsfor sensing any other kind of useful physiological parameter may beused.

Many different kinds of sensors that sense functional parameters of theapparatus may also be used for the control of the stimulation device.For example sensors for sensing electric parameters of implantedelectric components of the apparatus, or sensors for sensing theperformance of implanted components of the apparatus. The sensor maycomprise a pressure sensor for sensing as the physiological parameter apressure in the patient's body that relates to the pressure in theerectile blood flow passageway of the patient's erectile blood flowpassageway, wherein the control device controls stimulation device tochange the constriction of the patient's wall portion of the erectileblood flow passageway in response to the pressure sensor sensing apredetermined value of measured pressure.

The above described sensors may be used in any of the embodiments of theinvention, where applicable.

The control device may comprise an implantable internal control unitthat directly controls the stimulation device in response to signalsfrom the sensor. The control device may further comprise a wirelessremote control adapted to set control parameters of the internal controlunit from outside the patient without mechanically penetrating thepatient. At least one of the control parameters, which is settable bythe wireless remote control, is the physiological or functionalparameter. Alternatively, the control device may comprise an externalcontrol unit outside the patient's body for controlling the stimulationdevice in response to signals from the sensor.

In a preferred embodiment, the system comprises at least one switchimplantable in the patient for manually and non-invasively controllingthe apparatus

In another preferred embodiment, the system comprises a wireless remotecontrol for non-invasively controlling the apparatus.

In a third aspect there is provided an operation method using anapparatus as described above, comprising the steps of:

-   -   creating an opening in the skin or vaginal wall of the female        patient    -   dissecting at least one area of the female erectile tissue    -   placing the stimulation device within said area, adapted to        postoperatively stimulate said female erectile tissue on patient        command.

In one embodiment there is provided an operation method, furthercomprising the step of controlling said stimulation devicepost-operatively and non-invasively from outside the body.

In one embodiment there is provided an operation method, furthercomprising the step of placing a power source within the body.

In one embodiment there is provided an operation method, wherein thestep of placing a stimulation device comprises placing an integratedunit comprising the stimulation device and a power source in the sameintegrated unit.

In one embodiment there is provided an operation method, wherein thestep of placing a power source comprises the step of placing a controlunit and a rechargeable battery remote from the stimulation device.

In one embodiment there is provided an operation method, wherein thestep of placing a stimulation device comprises placing electrodes and anelectrical wire connected to a power source.

In one embodiment there is provided an operation method, wherein thestep of creating an opening in the skin or vaginal wall of the femalepatient comprises:

-   -   inserting a tube or needle into the patients body,    -   filling the body through the tube or needle with a gas and        thereby expanding a cavity within the female patients body,    -   inserting at least two laparoscopic trocars into said cavity,    -   inserting at least one camera trough at least one laparoscopic        trocar, and    -   inserting at least one dissecting tool through at least one        laparoscopic trocar.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will now be described in more detail by way ofnon-limiting embodiments and with reference to the accompanyingdrawings, in which:

FIG. 1 a schematically illustrates an apparatus and a system implantedin a female patient.

FIGS. 1 b to 1 d shows different embodiment of the sexual dysfunctionapparatus and the system according to the invention.

FIGS. 2-16 schematically show various embodiments of the system forwirelessly powering the apparatus shown in FIG. 1.

FIG. 17 is a schematic block diagram illustrating an arrangement forsupplying an accurate amount of energy used for the operation of theapparatus shown in FIG. 1.

FIG. 18 schematically shows an embodiment of the system, in which theapparatus is operated with wire bound energy.

FIG. 19 is a more detailed block diagram of an arrangement forcontrolling the transmission of wireless energy used for the operationof the apparatus shown in FIG. 1.

FIG. 20 is a circuit for the arrangement shown in FIG. 19, according toa possible implementation example.

FIGS. 21-27C show various ways of arranging hydraulic or pneumaticpowering of an apparatus implanted in a patient.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 a is a schematic picture of patient having an apparatus 10implanted, comprising a subcutaneously implanted control device 1002 andtwo stimulation devices 1001.

FIG. 1 b is a detailed illustration of the apparatus 10 and the system300. The stimulation devices 1001, here illustrates as electrodesoperable to stimulate the veins, is implanted to stimulate veins 204 ofthe female erectile tissue 205 of the patient. They are connected to thecontrol device 1002 trough a power supply line 1003. An externalenergy-transmission device 1004 for energizing the apparatus transmitsenergy by at least one wireless energy signal. The system can becontrolled with a remote control 1089. Also a subcutaneous controlswitch 1006 can be used to control the apparatus. In one embodiment asensor 1044 measures at least one physiological or functional parameter.The location of the sensor 1044 is adapted to the circumstances, e.g.which parameter that should be measured. The control device 1002 cancomprise at least one item selected from the group consisting of: aninternal control unit 1041 for communication, an internal energy source1042, a sensor control unit 1043, and an energy transforming device fortransforming wireless energy from the energy transmission device 1004.If a non-rechargeable battery is used the energy-transforming device1044 may be omitted but the other mentioned items may be used assuitable. In general, any item, or combinations of items, described andsuited therefore, may be connected to the stimulation device and asensor contacting the female organ via the connection line 1003. If e.g.the apparatus 10 is electrically operated it may be suitable to connectit to a source of electrical energy 1042 via the connection line 1003which in this case may be an electrical conduit. The control unit 1041may be connected to the source of electrical energy 1042.

FIG. 1 c shows two stimulation devices 1001 implanted as to engage veinsof the corpora cavernosa. Other parts of the apparatus are not.

FIG. 1 d demonstrates an alternative embodiment wherein the stimulationdevice is represented by different units 1001A and 1001B each operatingon parts of the corpora cavernosa for its direct stimulation to obtainengorgement of the tissue.

FIG. 2 illustrates the system of FIG. 1 in the form of a moregeneralized block diagram showing the apparatus 10, theenergy-transforming device 302 powering the apparatus 10 via powersupply line 303, and the external energy-transmission device 304. Thepatient's skin 305, generally shown by a vertical line, separates theinterior of the patient to the right of the line from the exterior tothe left of the line. The implanted energy-transforming device 302 isadapted to supply energy consuming components of the apparatus withenergy via a power supply line 303. An external energy-transmissiondevice 304 for non-invasively energizing the apparatus 10 transmitsenergy by at least one wireless energy signal. The implantedenergy-transforming device 302 transforms energy from the wirelessenergy signal into electric energy which is supplied via the powersupply line 303.

The wireless energy signal may include a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. Alternatively, the wireless energy signal may includean electric or magnetic field, or a combined electric and magneticfield.

The wireless energy-transmission device 304 may transmit a carriersignal for carrying the wireless energy signal. Such a carrier signalmay include digital, analogue or a combination of digital and analoguesignals. In this case, the wireless energy signal includes an analogueor a digital signal, or a combination of an analogue and digital signal.

Generally speaking, the energy-transforming device 302 is provided fortransforming wireless energy of a first form transmitted by theenergy-transmission device 304 into energy of a second form, whichtypically is different from the energy of the first form. The implantedapparatus 10 is operable in response to the energy of the second form.The energy-transforming device 302 may directly power the apparatus withthe second form energy, as the energy-transforming device 302 transformsthe first form energy transmitted by the energy-transmission device 304into the second form energy. The system may further include animplantable accumulator, wherein the second form energy is used at leastpartly to charge the accumulator.

Alternatively, the wireless energy transmitted by theenergy-transmission device 304 may be used to directly power theapparatus, as the wireless energy is being transmitted by theenergy-transmission device 304. Where the system comprises an operationdevice for operating the apparatus, as will be described below, thewireless energy transmitted by the energy-transmission device 304 may beused to directly power the operation device to create kinetic energy forthe operation of the apparatus. The wireless energy of the first formmay comprise sound waves and the energy-transforming device 302 mayinclude a piezo-electric element for transforming the sound waves intoelectric energy. The energy of the second form may comprise electricenergy in the form of a direct current or pulsating direct current, or acombination of a direct current and pulsating direct current, or analternating current or a combination of a direct and alternatingcurrent. Normally, the apparatus comprises electric components that areenergized with electrical energy. Other implantable electric componentsof the system may be at least one voltage level guard or at least oneconstant current guard connected with the electric components of theapparatus.

Optionally, one of the energy of the first form and the energy of thesecond form may comprise magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy or thermal energy. Preferably, one of the energy of thefirst form and the energy of the second form is non-magnetic,non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy-transmission device may be controlled from outside thepatient's body to release electromagnetic wireless energy, and thereleased electromagnetic wireless energy is used for operating theapparatus. Alternatively, the energy-transmission device is controlledfrom outside the patient's body to release non-magnetic wireless energy,and the released non-magnetic wireless energy is used for operating theapparatus.

The external energy-transmission device 304 also includes a wirelessremote control having an external signal transmitter for transmitting awireless control signal for non-invasively controlling the apparatus.The control signal is received by an implanted signal receiver which maybe incorporated in the implanted energy-transforming device 302 or beseparate there from.

The wireless control signal may include a frequency, amplitude, or phasemodulated signal or a combination thereof. Alternatively, the wirelesscontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal. Alternatively, thewireless control signal comprises an electric or magnetic field, or acombined electric and magnetic field.

The wireless remote control may transmit a carrier signal for carryingthe wireless control signal. Such a carrier signal may include digital,analogue or a combination of digital and analogue signals. Where thecontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal, the wireless remotecontrol preferably transmits an electromagnetic carrier wave signal forcarrying the digital or analogue control signals.

FIG. 3 shows an embodiment of the invention identical to that of FIG. 2,except that a reversing device in the form of an electric switch 306operable for example by polarized energy also is implanted in thepatient for reversing the apparatus 10. When the switch is operated bypolarized energy the wireless remote control of the externalenergy-transmission device 304 transmits a wireless signal that carriespolarized energy and the implanted energy-transforming device 302transforms the wireless polarized energy into a polarized current foroperating the electric switch 306. When the polarity of the current isshifted by the implanted energy-transforming device 302 the electricswitch 306 reverses the function performed by the apparatus 10.

FIG. 4 shows an embodiment of the invention identical to that of FIG. 2,except that an operation device 307 implanted in the patient foroperating the apparatus 10 is provided between the implantedenergy-transforming device 302 and the apparatus 10. This operationdevice can be in the form of a motor 307, such as an electricservomotor. The motor 307 is powered with energy from the implantedenergy-transforming device 302, as the remote control of the externalenergy-transmission device 304 transmits a wireless signal to thereceiver of the implanted energy-transforming device 302.

In all of these embodiments the energy-transforming device 302 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the system.

As an alternative, the wireless remote control described above may bereplaced by manual control of any implanted part to make contact with bythe patient's hand most likely indirect, for example a press buttonplaced under the skin.

FIG. 5 shows an embodiment of the invention identical to that of FIG. 2,except that it also comprises an operation device is in the form of anassembly 308 including a motor/pump unit 309 and a fluid reservoir 310is implanted in the patient. In this case the apparatus 10 ishydraulically operated, i.e. hydraulic fluid is pumped by the motor/pumpunit 309 from the fluid reservoir 310 through a conduit 311 to theapparatus 10 to operate the apparatus, and hydraulic fluid is pumped bythe motor/pump unit 309 back from the apparatus 10 to the fluidreservoir 310 to return the apparatus to a starting position. Theimplanted energy-transforming device 398 transforms wireless energy intoa current, for example a polarized current, for powering the motor/pumpunit 309 via an electric power supply line 312.

Instead of a hydraulically operated apparatus 10, it is also envisagedthat the operation device comprises a pneumatic operation device. Inthis case, the hydraulic fluid can be pressurized air to be used forregulation and the fluid reservoir is replaced by an air chamber.

In all of these embodiments the energy-transforming device 398 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the system.

As an alternative, the wireless remote control described above may bereplaced by manual control of any implanted part to make contact with bythe patient's hand most likely indirect, for example a press buttonplaced under the skin.

FIG. 6 shows an embodiment of the invention comprising the externalenergy-transmission device 304 with its wireless remote control, theapparatus 10, in this case hydraulically operated, and the implantedenergy-transforming device 398, and further comprising a hydraulic fluidreservoir 313, a motor/pump unit 309 and an reversing device in the formof a hydraulic valve shifting device 314, all implanted in the patient.Of course the hydraulic operation could easily be performed by justchanging the pumping direction and the hydraulic valve may therefore beomitted. The remote control may be a device separated from the externalenergy-transmission device or included in the same. The motor of themotor/pump unit 309 is an electric motor. In response to a controlsignal from the wireless remote control of the externalenergy-transmission device 304, the implanted energy-transforming device398 powers the motor/pump unit 309 with energy from the energy carriedby the control signal, whereby the motor/pump unit 309 distributeshydraulic fluid between the hydraulic fluid reservoir 313 and theapparatus 10. The remote control of the external energy-transmissiondevice 304 controls the hydraulic valve shifting device 314 to shift thehydraulic fluid flow direction between one direction in which the fluidis pumped by the motor/pump unit 309 from the hydraulic fluid reservoir313 to the apparatus 10 to operate the apparatus, and another oppositedirection in which the fluid is pumped by the motor/pump unit 309 backfrom the apparatus 10 to the hydraulic fluid reservoir 313 to return theapparatus to a starting position.

FIG. 7 shows an embodiment of the invention comprising the externalenergy-transmission device 304 with its wireless remote control, theapparatus 10, the implanted energy-transforming device 302, an implantedinternal control unit 315 controlled by the wireless remote control ofthe external energy-transmission device 304, an implanted accumulator316 and an implanted capacitor 317. The internal control unit 315arranges storage of electric energy received from the implantedenergy-transforming device 302 in the accumulator 316, which suppliesenergy to the apparatus 10. In response to a control signal from thewireless remote control of the external energy-transmission device 304,the internal control unit 315 either releases electric energy from theaccumulator 316 and transfers the released energy via power lines 318and 319, or directly transfers electric energy from the implantedenergy-transforming device 302 via a power line 320, the capacitor 317,which stabilizes the electric current, a power line 321 and the powerline 319, for the operation of the apparatus 10.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the apparatus 10 according to a pre-programmedtime-schedule or to input from any sensor sensing any possiblephysiological parameter of the patient or any functional parameter ofthe system.

In accordance with an alternative, the capacitor 317 in the embodimentof FIG. 7 10 may be omitted. In accordance with another alternative, theaccumulator 316 in this embodiment may be omitted.

FIG. 8 shows an embodiment of the invention identical to that of FIG. 2,except that a battery 322 for supplying energy for the operation of theapparatus 10 and an electric switch 323 for switching the operation ofthe apparatus 10 also are implanted in the patient. The electric switch323 may be controlled by the remote control and may also be operated bythe energy supplied by the implanted energy-transforming device 302 toswitch from an off mode, in which the battery 322 is not in use, to anon mode, in which the battery 322 supplies energy for the operation ofthe apparatus 10.

FIG. 9 shows an embodiment of the invention identical to that of FIG. 8,except that an internal control unit 315 controllable by the wirelessremote control of the external energy-transmission device 304 also isimplanted in the patient. In this case, the electric switch 323 isoperated by the energy supplied by the implanted energy-transformingdevice 302 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the internal control unit 315 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 315 to releaseelectric energy from the battery 322 for the operation of the apparatus10.

FIG. 10 shows an embodiment of the invention identical to that of FIG.9, except that an accumulator 316 is substituted for the battery 322 andthe implanted components are interconnected differently. In this case,the accumulator 316 stores energy from the implanted energy-transformingdevice 302. In response to a control signal from the wireless remotecontrol of the external energy-transmission device 304, the internalcontrol unit 315 controls the electric switch 323 to switch from an offmode, in which the accumulator 316 is not in use, to an on mode, inwhich the accumulator 316 supplies energy for the operation of theapparatus 10. The accumulator may be combined with or replaced by acapacitor.

FIG. 11 shows an embodiment of the invention identical to that of FIG.10, except that a battery 322 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 304, the internal control unit 315 controlsthe accumulator 316 to deliver energy for operating the electric switch323 to switch from an off mode, in which the battery 322 is not in use,to an on mode, in which the battery 322 supplies electric energy for theoperation of the apparatus 10.

Alternatively, the electric switch 323 may be operated by energysupplied by the accumulator 316 to switch from an off mode, in which thewireless remote control is prevented from controlling the battery 322 tosupply electric energy and is not in use, to a standby mode, in whichthe wireless remote control is permitted to control the battery 322 tosupply electric energy for the operation of the apparatus 10.

It should be understood that the switch 323 and all other switches inthis application should be interpreted in its broadest embodiment. Thismeans a transistor, MCU, MCPU, ASIC, FPGA or a DA converter or any otherelectronic component or circuit that may switch the power on and off.Preferably the switch is controlled from outside the body, oralternatively by an implanted internal control unit.

FIG. 12 shows an embodiment of the invention identical to that of FIG.8, except that a motor 307, a mechanical reversing device in the form ofa gear box 324, and an internal control unit 315 for controlling thegear box 324 also are implanted in the patient. The internal controlunit 315 controls the gear box 324 to reverse the function performed bythe apparatus 10 (mechanically operated). Even simpler is to switch thedirection of the motor electronically. The gear box interpreted in itsbroadest embodiment may stand for a servo arrangement saving force forthe operation device in favour of longer stroke to act.

FIG. 13 shows an embodiment of the invention identical to that of FIG.19 except that the implanted components are interconnected differently.Thus, in this case the internal control unit 315 is powered by thebattery 322 when the accumulator 316, suitably a capacitor, activatesthe electric switch 323 to switch to an on mode. When the electricswitch 323 is in its on mode the internal control unit 315 is permittedto control the battery 322 to supply, or not supply, energy for theoperation of the apparatus 10.

FIG. 14 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communication options.Basically, there are the apparatus 10, the internal control unit 315,motor or pump unit 309, and the external energy-transmission device 304including the external wireless remote control. As already describedabove the wireless remote control transmits a control signal which isreceived by the internal control unit 315, which in turn controls thevarious implanted components of the apparatus.

A feedback device, preferably comprising a sensor or measuring device325, may be implanted in the patient for sensing a physiologicalparameter of the patient. The physiological parameter may be at leastone selected from the group consisting of pressure, volume, diameter,stretching, elongation, extension, movement, bending, elasticity, musclecontraction, nerve impulse, body temperature, blood pressure, bloodflow, heartbeats and breathing. The sensor may sense any of the abovephysiological parameters. For example, the sensor may be a pressure ormotility sensor. Alternatively, the sensor 325 may be arranged to sensea functional parameter. The functional parameter may be correlated tothe transfer of energy for charging an implanted energy source and mayfurther include at least one selected from the group of parametersconsisting of; electricity, any electrical parameter, pressure, volume,diameter, stretch, elongation, extension, movement, bending, elasticity,temperature and flow.

The feedback may be sent to the internal control unit or out to anexternal control unit preferably via the internal control unit. Feedbackmay be sent out from the body via the energy transfer system or aseparate communication system with receiver and transmitters. Theinternal control unit 315, or alternatively the external wireless remotecontrol of the external energy-transmission device 304, may control theapparatus 10 in response to signals from the sensor 325. A transceivermay be combined with the sensor 325 for sending information on thesensed physiological parameter to the external wireless remote control.The wireless remote control may comprise a signal transmitter ortransceiver and the internal control unit 315 may comprise a signalreceiver or transceiver. Alternatively, the wireless remote control maycomprise a signal receiver or transceiver and the internal control unit315 may comprise a signal transmitter or transceiver. The abovetransceivers, transmitters and receivers may be used for sendinginformation or data related to the apparatus 10 from inside thepatient's body to the outside thereof. Where the motor/pump unit 309 andbattery 322 for powering the motor/pump unit 309 are implanted,information related to the charging of the battery 322 may be fed back.To be more precise, when charging a battery or accumulator with energyfeedback information related to said charging process is sent and theenergy supply is changed accordingly.

FIG. 15 shows an alternative embodiment wherein the apparatus 10 isregulated from outside the patient's body. The system 300 comprises abattery 322 connected to the apparatus 10 via a subcutaneous electricswitch 326. Thus, the regulation of the apparatus 10 is performednon-invasively by manually pressing the subcutaneous switch, whereby theoperation of the apparatus 10 is switched on and off. It will beappreciated that the shown embodiment is a simplification and thatadditional components, such as an internal control unit or any otherpart disclosed in the present application can be added to the system.Two subcutaneous switches may also be used. In the preferred embodimentone implanted switch sends information to the internal control unit toperform a certain predetermined performance and when the patient pressthe switch again the performance is reversed.

FIG. 16 shows an alternative embodiment, wherein the system 300comprises a hydraulic fluid reservoir 313 hydraulically connected to theapparatus. Non-invasive regulation is performed by manually pressing thehydraulic reservoir connected to the apparatus.

The system may include an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator. The internal communicator feeds data related to theapparatus or the patient to the external data communicator and/or theexternal data communicator feeds data to the internal data communicator.

FIG. 17 schematically illustrates an arrangement of the system that iscapable of sending information from inside the patient's body to theoutside thereof to give feedback information related to at least onefunctional parameter of the apparatus or system, or related to aphysiological parameter of the patient, in order to supply an accurateamount of energy to an implanted internal energy receiver 302 connectedto implanted energy consuming components of the apparatus 10. Such anenergy receiver 302 may include an energy source and/or anenergy-transforming device. Briefly described, wireless energy istransmitted from an external energy source 304 a located outside thepatient and is received by the internal energy receiver 302 locatedinside the patient. The internal energy receiver is adapted to directlyor indirectly supply received energy to the energy consuming componentsof the apparatus 10 via a switch 326. An energy balance is determinedbetween the energy received by the internal energy receiver 302 and theenergy used for the apparatus 10, and the transmission of wirelessenergy is then controlled based on the determined energy balance. Theenergy balance thus provides an accurate indication of the correctamount of energy needed, which is sufficient to operate the apparatus 10properly, but without causing undue temperature rise.

In FIG. 17 the patient's skin is indicated by a vertical line 305. Here,the energy receiver comprises an energy-transforming device 302 locatedinside the patient, preferably just beneath the patient's skin 305.Generally speaking, the implanted energy-transforming device 302 may beplaced in the abdomen, thorax, muscle fascia (e.g. in the abdominalwall), subcutaneously, or at any other suitable location. The implantedenergy-transforming device 302 is adapted to receive wireless energy Etransmitted from the external energy-source 304 a provided in anexternal energy-transmission device 304 located outside the patient'sskin 305 in the vicinity of the implanted energy-transforming device302.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal energy source 304 a and an adjacent secondary coil arranged inthe implanted energy-transforming device 302. When an electric currentis fed through the primary coil, energy in the form of a voltage isinduced in the secondary coil which can be used to power the implantedenergy consuming components of the apparatus, e.g. after storing theincoming energy in an implanted energy source, such as a rechargeablebattery or a capacitor. However, the present invention is generally notlimited to any particular energy transfer technique, TET devices orenergy sources, and any kind of wireless energy may be used.

The amount of energy received by the implanted energy receiver may becompared with the energy used by the implanted components of theapparatus. The term “energy used” is then understood to include alsoenergy stored by implanted components of the apparatus. A control deviceincludes an external control unit 304 b that controls the externalenergy source 304 a based on the determined energy balance to regulatethe amount of transferred energy. In order to transfer the correctamount of energy, the energy balance and the required amount of energyis determined by means of a determination device including an implantedinternal control unit 315 connected between the switch 326 and theapparatus 10. The internal control unit 315 may thus be arranged toreceive various measurements obtained by suitable sensors or the like,not shown, measuring certain characteristics of the apparatus 10,somehow reflecting the required amount of energy needed for properoperation of the apparatus 10. Moreover, the current condition of thepatient may also be detected by means of suitable measuring devices orsensors, in order to provide parameters reflecting the patient'scondition. Hence, such characteristics and/or parameters may be relatedto the current state of the apparatus 10, such as power consumption,operational mode and temperature, as well as the patient's conditionreflected by parameters such as; body temperature, blood pressure,heartbeats and breathing. Other kinds of physiological parameters of thepatient and functional parameters of the device are described elsewhere.

Furthermore, an energy source in the form of an accumulator 316 mayoptionally be connected to the implanted energy-transforming device 302via the control unit 315 for accumulating received energy for later useby the apparatus 10. Alternatively or additionally, characteristics ofsuch an accumulator, also reflecting the required amount of energy, maybe measured as well. The accumulator may be replaced by a rechargeablebattery, and the measured characteristics may be related to the currentstate of the battery, any electrical parameter such as energyconsumption voltage, temperature, etc. In order to provide sufficientvoltage and current to the apparatus 10, and also to avoid excessiveheating, it is clearly understood that the battery should be chargedoptimally by receiving a correct amount of energy from the implantedenergy-transforming device 302, i.e. not too little or too much. Theaccumulator may also be a capacitor with corresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 315. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 315 of the determination device isadapted to determine the energy balance and/or the currently requiredamount of energy, (either energy per time unit or accumulated energy)based on measurements made by the above-mentioned sensors or measuringdevices of the apparatus 10, or the patient, or an implanted energysource if used, or any combination thereof. The internal control unit315 is further connected to an internal signal transmitter 327, arrangedto transmit a control signal reflecting the determined required amountof energy, to an external signal receiver 304 c connected to theexternal control unit 304 b. The amount of energy transmitted from theexternal energy source 304 a may then be regulated in response to thereceived control signal. Alternatively, the determination device mayinclude the external control unit 304 b. In this alternative, sensormeasurements can be transmitted directly to the external control unit304 b wherein the energy balance and/or the currently required amount ofenergy can be determined by the external control unit 304 b, thusintegrating the above-described function of the internal control unit315 in the external control unit 304 b. In that case, the internalcontrol unit 315 can be omitted and the sensor measurements are supplieddirectly to the internal signal transmitter 327 which sends themeasurements over to the external signal receiver 304 c and the externalcontrol unit 304 b. The energy balance and the currently required amountof energy can then be determined by the external control unit 304 bbased on those sensor measurements. Hence, the present solutionaccording to the arrangement of FIG. 17 employs the feed back ofinformation indicating the required energy, which is more efficient thanprevious solutions because it is based on the actual use of energy thatis compared to the received energy, e.g. with respect to the amount ofenergy, the energy difference, or the energy receiving rate as comparedto the energy rate used by implanted energy consuming components of theapparatus. The apparatus may use the received energy either forconsuming or for storing the energy in an implanted energy source or thelike. The different parameters discussed above would thus be used ifrelevant and needed and then as a tool for determining the actual energybalance. However, such parameters may also be needed per se for anyactions taken internally to specifically operate the apparatus.

The internal signal transmitter 327 and the external signal receiver 304c may be implemented as separate units using suitable signal transfermeans, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 327 and the externalsignal receiver 304 c may be integrated in the implantedenergy-transforming device 302 and the external energy source 304 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

Thus, the feedback information may be transferred either by a separatecommunication system including receivers and transmitters or may beintegrated in the energy system. In accordance with the presentinvention, such an integrated information feedback and energy systemcomprises an implantable internal energy receiver for receiving wirelessenergy, the energy receiver having an internal first coil and a firstelectronic circuit connected to the first coil, and an external energytransmitter for transmitting wireless energy, the energy transmitterhaving an external second coil and a second electronic circuit connectedto the second coil. The external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver. This system further comprises a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off. Inimplementing this system in the arrangement of FIG. 17, the switch 326is either separate and controlled by the internal control unit 315, orintegrated in the internal control unit 315. It should be understoodthat the switch 326 should be interpreted in its broadest embodiment.This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or anyother electronic component or circuit that may switch the power on andoff.

To conclude, the energy supply arrangement illustrated in FIG. 17 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 315 of the determination device.A control signal reflecting the required amount of energy is alsocreated by the internal control unit 315, and the control signal istransmitted from the internal signal transmitter 327 to the externalsignal receiver 304 c. Alternatively, the energy balance can bedetermined by the external control unit 304 b instead depending on theimplementation, as mentioned above. In that case, the control signal maycarry measurement results from various sensors. The amount of energyemitted from the external energy source 304 a can then be regulated bythe external control unit 304 b, based on the determined energy balance,e.g. in response to the received control signal. This process may berepeated intermittently at certain intervals during ongoing energytransfer, or may be executed on a more or less continuous basis duringthe energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 304 a,such as voltage, current, amplitude, wave frequency and pulsecharacteristics.

This system may also be used to obtain information about the couplingfactors between the coils in a TET system even to calibrate the systemboth to find an optimal place for the external coil in relation to theinternal coil and to optimize energy transfer. Simply comparing in thiscase the amount of energy transferred with the amount of energyreceived. For example if the external coil is moved the coupling factormay vary and correctly displayed movements could cause the external coilto find the optimal place for energy transfer. Preferably, the externalcoil is adapted to calibrate the amount of transferred energy to achievethe feedback information in the determination device, before thecoupling factor is maximized.

This coupling factor information may also be used as a feedback duringenergy transfer. In such a case, the energy system of the presentinvention comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmits wireless energy which is received by thefirst coil of the energy receiver. This system further comprises afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorbetween the first and second coils. The energy transmitter may regulatethe transmitted energy in response to the obtained coupling factor.

With reference to FIG. 18, although wireless transfer of energy foroperating the apparatus has been described above to enable non-invasiveoperation, it will be appreciated that the apparatus can be operatedwith wire bound energy as well. Such an example is shown in FIG. 18,wherein an external switch 326 is interconnected between the externalenergy source 304 a and an operation device, such as an electric motor307 operating the apparatus 10. An external control unit 304 b controlsthe operation of the external switch 326 to effect proper operation ofthe apparatus 10.

FIG. 19 illustrates different embodiments for how received energy can besupplied to and used by the apparatus 10. Similar to the example of FIG.17, an internal energy receiver 302 receives wireless energy E from anexternal energy source 304 a which is controlled by a transmissioncontrol unit 304 b. The internal energy receiver 302 may comprise aconstant voltage circuit, indicated as a dashed box “constant V” in thefigure, for supplying energy at constant voltage to the apparatus 10.The internal energy receiver 302 may further comprise a constant currentcircuit, indicated as a dashed box “constant C” in the figure, forsupplying energy at constant current to the apparatus 10.

The apparatus 10 comprises an energy consuming part 10 a, which may be amotor, pump, restriction device, or any other medical appliance thatrequires energy for its electrical operation. The apparatus 10 mayfurther comprise an energy storage device 10 b for storing energysupplied from the internal energy receiver 302. Thus, the suppliedenergy may be directly consumed by the energy consuming part 10 a, orstored by the energy storage device 10 b, or the supplied energy may bepartly consumed and partly stored. The apparatus 10 may further comprisean energy stabilizing unit 10 c for stabilizing the energy supplied fromthe internal energy receiver 302. Thus, the energy may be supplied in afluctuating manner such that it may be necessary to stabilize the energybefore consumed or stored.

The energy supplied from the internal energy receiver 302 may further beaccumulated and/or stabilized by a separate energy stabilizing unit 328located outside the apparatus 10, before being consumed and/or stored bythe apparatus 10. Alternatively, the energy stabilizing unit 328 may beintegrated in the internal energy receiver 302. In either case, theenergy stabilizing unit 328 may comprise a constant voltage circuitand/or a constant current circuit.

It should be noted that FIG. 17 and FIG. 19 illustrate some possible butnon-limiting implementation options regarding how the various shownfunctional components and elements can be arranged and connected to eachother. However, the skilled person will readily appreciate that manyvariations and modifications can be made within the scope of the presentinvention.

FIG. 20 schematically shows an energy balance measuring circuit of oneof the proposed designs of the system for controlling transmission ofwireless energy, or energy balance control system. The circuit has anoutput signal centered on 2.5V and proportionally related to the energyimbalance. The derivative of this signal shows if the value goes up anddown and how fast such a change takes place. If the amount of receivedenergy is lower than the energy used by implanted components of theapparatus, more energy is transferred and thus charged into the energysource. The output signal from the circuit is typically feed to an A/Dconverter and converted into a digital format. The digital informationcan then be sent to the external energy-transmission device allowing itto adjust the level of the transmitted energy. Another possibility is tohave a completely analog system that uses comparators comparing theenergy balance level with certain maximum and minimum thresholds sendinginformation to external energy-transmission device if the balance driftsout of the max/min window.

The schematic FIG. 20 shows a circuit implementation for a system thattransfers energy to the implanted energy components of the apparatus ofthe present invention from outside of the patient's body using inductiveenergy transfer. An inductive energy transfer system typically uses anexternal transmitting coil and an internal receiving coil. The receivingcoil, L1, is included in the schematic FIG. 3; the transmitting parts ofthe system are excluded.

The implementation of the general concept of energy balance and the waythe information is transmitted to the external energy transmitter can ofcourse be implemented in numerous different ways. The schematic FIG. 20and the above described method of evaluating and transmitting theinformation should only be regarded as examples of how to implement thecontrol system.

Circuit Details

In FIG. 20 the symbols Y1, Y2, Y3 and so on symbolize test points withinthe circuit. The components in the diagram and their respective valuesare values that work in this particular implementation which of courseis only one of an infinite number of possible design solutions.

Energy to power the circuit is received by the energy receiving coil L1.Energy to implanted components is transmitted in this particular case ata frequency of 25 kHz. The energy balance output signal is present attest point Y1.

Those skilled in the art will realize that the above various embodimentsof the system could be combined in many different ways. For example, theelectric switch 306 of FIG. 3 could be incorporated in any of theembodiments of FIGS. 6-12, the hydraulic valve shifting device 314 ofFIG. 6 could be incorporated in the embodiment of FIG. 5, and the gearbox 324 could be incorporated in the embodiment of FIG. 4. Pleaseobserve that the switch simply could mean any electronic circuit orcomponent. The embodiments described in connection with FIGS. 17, 19 and20 identify a method and a system for controlling transmission ofwireless energy to implanted energy consuming components of anelectrically operable apparatus. Such a method and system will bedefined in general terms in the following.

A method is thus provided for controlling transmission of wirelessenergy supplied to implanted energy consuming components of an apparatusas described above. The wireless energy E is transmitted from anexternal energy source located outside the patient and is received by aninternal energy receiver located inside the patient, the internal energyreceiver being connected to the implanted energy consuming components ofthe apparatus for directly or indirectly supplying received energythereto. An energy balance is determined between the energy received bythe internal energy receiver and the energy used for the apparatus. Thetransmission of wireless energy E from the external energy source isthen controlled based on the determined energy balance.

The wireless energy may be transmitted inductively from a primary coilin the external energy source to a secondary coil in the internal energyreceiver. A change in the energy balance may be detected to control thetransmission of wireless energy based on the detected energy balancechange. A difference may also be detected between energy received by theinternal energy receiver and energy used for the medical device, tocontrol the transmission of wireless energy based on the detected energydifference.

When controlling the energy transmission, the amount of transmittedwireless energy may be decreased if the detected energy balance changeimplies that the energy balance is increasing, or vice versa. Thedecrease/increase of energy transmission may further correspond to adetected change rate.

The amount of transmitted wireless energy may further be decreased ifthe detected energy difference implies that the received energy isgreater than the used energy, or vice versa. The decrease/increase ofenergy transmission may then correspond to the magnitude of the detectedenergy difference.

As mentioned above, the energy used for the medical device may beconsumed to operate the medical device, and/or stored in at least oneenergy storage device of the medical device.

When electrical and/or physiological parameters of the medical deviceand/or physiological parameters of the patient are determined, theenergy may be transmitted for consumption and storage according to atransmission rate per time unit which is determined based on saidparameters. The total amount of transmitted energy may also bedetermined based on said parameters.

When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to said energy balance, the integral may be determined for amonitored voltage and/or current related to the energy balance.

When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thederivative may be determined for a monitored voltage and/or currentrelated to the energy balance.

The transmission of wireless energy from the external energy source maybe controlled by applying to the external energy source electricalpulses from a first electric circuit to transmit the wireless energy,the electrical pulses having leading and trailing edges, varying thelengths of first time intervals between successive leading and trailingedges of the electrical pulses and/or the lengths of second timeintervals between successive trailing and leading edges of theelectrical pulses, and transmitting wireless energy, the transmittedenergy generated from the electrical pulses having a varied power, thevarying of the power depending on the lengths of the first and/or secondtime intervals.

In that case, the frequency of the electrical pulses may besubstantially constant when varying the first and/or second timeintervals. When applying electrical pulses, the electrical pulses mayremain unchanged, except for varying the first and/or second timeintervals. The amplitude of the electrical pulses may be substantiallyconstant when varying the first and/or second time intervals. Further,the electrical pulses may be varied by only varying the lengths of firsttime intervals between successive leading and trailing edges of theelectrical pulses.

A train of two or more electrical pulses may be supplied in a row,wherein when applying the train of pulses, the train having a firstelectrical pulse at the start of the pulse train and having a secondelectrical pulse at the end of the pulse train, two or more pulse trainsmay be supplied in a row, wherein the lengths of the second timeintervals between successive trailing edge of the second electricalpulse in a first pulse train and leading edge of the first electricalpulse of a second pulse train are varied.

When applying the electrical pulses, the electrical pulses may have asubstantially constant current and a substantially constant voltage. Theelectrical pulses may also have a substantially constant current and asubstantially constant voltage. Further, the electrical pulses may alsohave a substantially constant frequency. The electrical pulses within apulse train may likewise have a substantially constant frequency.

The circuit formed by the first electric circuit and the external energysource may have a first characteristic time period or first timeconstant, and when effectively varying the transmitted energy, suchfrequency time period may be in the range of the first characteristictime period or time constant or shorter.

A system comprising an apparatus as described above is thus alsoprovided for controlling transmission of wireless energy supplied toimplanted energy consuming components of the apparatus. In its broadestsense, the system comprises a control device for controlling thetransmission of wireless energy from an energy-transmission device, andan implantable internal energy receiver for receiving the transmittedwireless energy, the internal energy receiver being connected toimplantable energy consuming components of the apparatus for directly orindirectly supplying received energy thereto. The system furthercomprises a determination device adapted to determine an energy balancebetween the energy received by the internal energy receiver and theenergy used for the implantable energy consuming components of theapparatus, wherein the control device controls the transmission ofwireless energy from the external energy-transmission device, based onthe energy balance determined by the determination device.

Further, the system may comprise any of the following:

-   -   A primary coil in the external energy source adapted to transmit        the wireless energy inductively to a secondary coil in the        internal energy receiver.    -   The determination device is adapted to detect a change in the        energy balance, and the control device controls the transmission        of wireless energy based on the detected energy balance change    -   The determination device is adapted to detect a difference        between energy received by the internal energy receiver and        energy used for the implantable energy consuming components of        the apparatus, and the control device controls the transmission        of wireless energy based on the detected energy difference.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy balance change implies that the energy        balance is increasing, or vice versa, wherein the        decrease/increase of energy transmission corresponds to a        detected change rate.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy difference implies that the received energy        is greater than the used energy, or vice versa, wherein the        decrease/increase of energy transmission corresponds to the        magnitude of said detected energy difference.    -   The energy used for the apparatus is consumed to operate the        apparatus, and/or stored in at least one energy storage device        of the apparatus.    -   Where electrical and/or physiological parameters of the        apparatus and/or physiological parameters of the patient are        determined, the energy-transmission device transmits the energy        for consumption and storage according to a transmission rate per        time unit which is determined by the determination device based        on said parameters. The determination device also determines the        total amount of transmitted energy based on said parameters.    -   When a difference is detected between the total amount of energy        received by the internal energy receiver and the total amount of        consumed and/or stored energy, and the detected difference is        related to the integral over time of at least one measured        electrical parameter related to the energy balance, the        determination device determines the integral for a monitored        voltage and/or current related to the energy balance.    -   When the derivative is determined over time of a measured        electrical parameter related to the amount of consumed and/or        stored energy, the determination device determines the        derivative for a monitored voltage and/or current related to the        energy balance.    -   The energy-transmission device comprises a coil placed        externally to the human body, and an electric circuit is        provided to power the external coil with electrical pulses to        transmit the wireless energy. The electrical pulses have leading        and trailing edges, and the electric circuit is adapted to vary        first time intervals between successive leading and trailing        edges and/or second time intervals between successive trailing        and leading edges of the electrical pulses to vary the power of        the transmitted wireless energy. As a result, the energy        receiver receiving the transmitted wireless energy has a varied        power.    -   The electric circuit is adapted to deliver the electrical pulses        to remain unchanged except varying the first and/or second time        intervals.    -   The electric circuit has a time constant and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the coil is varied.    -   The electric circuit is adapted to deliver the electrical pulses        to be varied by only varying the lengths of first time intervals        between successive leading and trailing edges of the electrical        pulses.    -   The electric circuit is adapted to supplying a train of two or        more electrical pulses in a row, said train having a first        electrical pulse at the start of the pulse train and having a        second electrical pulse at the end of the pulse train, and    -   the lengths of the second time intervals between successive        trailing edge of the second electrical pulse in a first pulse        train and leading edge of the first electrical pulse of a second        pulse train are varied by the first electronic circuit.    -   The electric circuit is adapted to provide the electrical pulses        as pulses having a substantially constant height and/or        amplitude and/or intensity and/or voltage and/or current and/or        frequency.    -   The electric circuit has a time constant, and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the first coil are varied.    -   The electric circuit is adapted to provide the electrical pulses        varying the lengths of the first and/or the second time        intervals only within a range that includes the first time        constant or that is located relatively close to the first time        constant, compared to the magnitude of the first time constant.

FIGS. 21-24 show in more detail block diagrams of four different ways ofhydraulically or pneumatically powering an implanted apparatus accordingto the invention.

FIG. 21 shows a system as described above with. The system comprises animplanted apparatus 10 and further a separate regulation reservoir 313,a one way pump 309 and an alternate valve 314.

FIG. 22 shows the apparatus 10 and a fluid reservoir 313. By moving thewall of the regulation reservoir or changing the size of the same in anyother different way, the adjustment of the apparatus may be performedwithout any valve, just free passage of fluid any time by moving thereservoir wall.

FIG. 23 shows the apparatus 10, a two way pump 309 and the regulationreservoir 313.

FIG. 24 shows a block diagram of a reversed servo system with a firstclosed system controlling a second closed system. The servo systemcomprises a regulation reservoir 313 and a servo reservoir 350. Theservo reservoir 350 mechanically controls an implanted apparatus 10 viaa mechanical interconnection 354. The apparatus has anexpandable/contactable cavity. This cavity is preferably expanded orcontracted by supplying hydraulic fluid from the larger adjustablereservoir 352 in fluid connection with the apparatus 10. Alternatively,the cavity contains compressible gas, which can be compressed andexpanded under the control of the servo reservoir 350.

The servo reservoir 350 can also be part of the apparatus itself.

In one embodiment, the regulation reservoir is placed subcutaneous underthe patient's skin and is operated by pushing the outer surface thereofby means of a finger. This system is illustrated in FIGS. 25 a-c. InFIG. 25 a, a flexible subcutaneous regulation reservoir 313 is shownconnected to a bulge shaped servo reservoir 350 by means of a conduit311. This bellow shaped servo reservoir 350 is comprised in a flexibleapparatus 10. In the state shown in FIG. 25 a, the servo reservoir 350contains a minimum of fluid and most fluid is found in the regulationreservoir 313. Due to the mechanical interconnection between the servoreservoir 350 and the apparatus 10, the outer shape of the apparatus 10is contracted, i.e., it occupies less than its maximum volume. Thismaximum volume is shown with dashed lines in the figure.

FIG. 25 b shows a state wherein a user, such as the patient in with theapparatus is implanted, presses the regulation reservoir 313 so thatfluid contained therein is brought to flow through the conduit 311 andinto the servo reservoir 350, which, thanks to its bellow shape, expandslongitudinally. This expansion in turn expands the apparatus 10 so thatit occupies its maximum volume.

The regulation reservoir 313 is preferably provided with means 313 a forkeeping its shape after compression. This means, which is schematicallyshown in the figure, will thus keep the apparatus 10 in a stretchedposition also when the user releases the regulation reservoir. In thisway, the regulation reservoir essentially operates as an on/off switchfor the system.

An alternative embodiment of hydraulic or pneumatic operation will nowbe described with reference to FIGS. 26 and 27 a-c. The block diagramshown in FIG. 26 comprises with a first closed system controlling asecond closed system. The first system comprises a regulation reservoir313 and a servo reservoir 350. The servo reservoir 350 mechanicallycontrols a larger adjustable reservoir 352 via a mechanicalinterconnection 354. An implanted apparatus 10 having anexpandable/contactable cavity is in turn controlled by the largeradjustable reservoir 352 by supply of hydraulic fluid from the largeradjustable reservoir 352 in fluid connection with the apparatus 10.

An example of this embodiment will now be described with reference toFIG. 27 a-c. Like in the previous embodiment, the regulation reservoiris placed subcutaneous under the patient's skin and is operated bypushing the outer surface thereof by means of a finger. The regulationreservoir 313 is in fluid connection with a bellow shaped servoreservoir 350 by means of a conduit 311. In the first closed system 313,311, 350 shown in FIG. 27 a, the servo reservoir 350 contains a minimumof fluid and most fluid is found in the regulation reservoir 313.

The servo reservoir 350 is mechanically connected to a larger adjustablereservoir 352, in this example also having a bellow shape but with alarger diameter than the servo reservoir 350. The larger adjustablereservoir 352 is in fluid connection with the apparatus 10. This meansthat when a user pushes the regulation reservoir 313, thereby displacingfluid from the regulation reservoir 313 to the servo reservoir 350, theexpansion of the servo reservoir 350 will displace a larger volume offluid from the larger adjustable reservoir 352 to the apparatus 10. Inother words, in this reversed servo, a small volume in the regulationreservoir is compressed with a higher force and this creates a movementof a larger total area with less force per area unit.

Like in the previous embodiment described above with reference to FIGS.25 a-c, the regulation reservoir 313 is preferably provided with means313 a (FIG. 27 c) for keeping its shape after compression. This means,which is schematically shown in the figure, will thus keep the apparatus10 in a stretched position also when the user releases the regulationreservoir. In this way, the regulation reservoir essentially operates asan on/off switch for the system.

Other features and uses of the invention and their associated advantageswill be evident to a person skilled in the art upon reading thedescription.

It is to be understood that this invention is not limited to theparticular embodiments shown here. The scope of the present invention islimited only by the appended claims and equivalents thereof.

1.-109. (canceled)
 110. A method for treating, operating, or treating and operating, a female patient with an apparatus or a system including the apparatus, comprising a stimulation device adapted to indirect stimulate an erectile blood flow passageway to increase the amount of blood in the female erectile tissue and thereby obtaining engorgement with blood of the female erectile tissue by indirect affecting said erectile blood flow passageway, the stimulation device is further adapted to stimulate a muscle related to arterial blood flow reaching the female erectile tissue, adapted to stimulate the muscle enough to relax the muscle to thereby cause relaxation of said muscle, to thereby increase the arterial blood flow, thereby obtaining said engorgement with blood of the female erectile tissue, wherein the method comprises: stimulating using the apparatus or system including the apparatus, described above, stimulating the muscle enough to thereby cause relaxation of said muscle, resulting in increasing the arterial blood flow, thereby obtaining said engorgement with blood of the female erectile tissue.
 111. The method according to claim 110 further comprising: a. creating an opening in the skin or vaginal wall of the female patient b. dissecting at least one area of the female erectile tissue c. placing the stimulation device within said area, adapted to postoperatively stimulate said female erectile tissue on patient command.
 112. The method according to claim 111, wherein the step of creating an opening in the skin or vaginal wall of the female patient comprises: inserting a tube or needle into the patient's body, filling the body through the tube or needle with a gas and thereby expanding a cavity within the female patients body, inserting at least two laparo- or endoscopic trocars into said cavity, inserting at least one camera trough at least one trocar, inserting at least one dissecting tool through at least one trocar.
 113. The method according to claim 110, wherein the step of stimulating is used for controlling said stimulation device during an operation.
 114. The method according to claim 111, wherein the step of placing the stimulation device, comprising the step of placing a power source within the body.
 115. The method according to claim 114, wherein the step of placing a stimulation device comprises placing an integrated unit comprising the stimulation device with the power source in the same integrated unit.
 116. The method according to claim 114, wherein the step of placing a power source comprises the step of placing a control unit and a rechargeable battery remote from the stimulation device.
 117. The method according to claim 114, wherein the step of placing a stimulation device comprises placing electrical electrodes and an electrical wire connected to a power source.
 118. The method according to claim 110, comprising the additional step of controlling said stimulation device post-operatively and non-invasively from outside the body.
 119. The method according to claim 112, comprising the additional operational step of placing a power source within the body.
 120. The method according to claim 119, wherein the step of placing a stimulation device comprises placing an integrated unit comprising the stimulation device with the power source in the same integrated unit.
 121. The method according to claim 119, wherein the step of placing a power source comprises the step of placing a control unit and a rechargeable battery remote from the stimulation device.
 122. The method according to claim 112, wherein the step of placing a stimulation device comprises placing electrical electrodes and an electrical wire connected to a power source.
 123. The method according to claim 110 further comprising the steps of, on the patient command: stimulating indirect the erectile blood flow passageway to increase the amount of blood in the female erectile tissue and thereby obtaining engorgement with blood of the female erectile tissue, when at least one of; using a wireless remote control, for non-invasively controlling the apparatus, and using at least one switch implanted in the patient for manually and non-invasively controlling the apparatus.
 124. The method according to claim 110 further comprising the step of controlling the level of stimulation using a control device.
 125. The method according to claim 110 further comprising: setting control parameters of an internal control unit from outside the patients body non-invasively, setting at least one physiological or functional parameter.
 126. The method according to claim 110, wherein the apparatus comprises a control device and at least one sensor adapted to detect a physiological parameter of the patient and/or a functional parameter of the apparatus, wherein the method further comprising the steps of; controlling by the control device the stimulation device in response to signals from the sensor, controlling automatically the stimulation device based on input from said at least one sensor.
 127. The method according to claim 110, wherein the apparatus comprises at least one of the following: at least one sensor; pressure sensor for sensing pressure in the erectile blood flow passageway, strain sensor for sensing strain of the erectile blood flow passageway, flow sensor for sensing blood flow in the lumen of the erectile blood flow passageway, spectrophoto-metrical sensor, or sensor for sensing the distribution of the stimulation on the stimulated erectile blood flow passageway, sensor for sensing electric parameters of implanted electric components of the apparatus, sensor for sensing the performance of implanted components of the apparatus, and a sensor for sensing any useful physiological parameter.
 128. The method according to claim 110 further comprising: sensing by a pressure sensor a physiological parameter being a pressure in the patient's body that relates to the pressure in the erectile blood flow passageway of the patient's erectile blood flow passageway, controlling by a control device the stimulation device to change the erectile blood flow passageway in response to the pressure sensor sensing a predetermined value of measured pressure.
 129. The method according to claim 120 further comprising controlling directly, by at least one of: an implantable internal control unit being part of a control device, the stimulation device in response to signals from the sensor, an external unit placed outside the patients body being part of a control device, the stimulation device in response to signals from the sensor. 